Glossary
Deviation
A departure from an approved instruction or an established standard.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, deviations were not recorded, and investigations were not conducted when microbiological test results were…
FDA · FDA Warning Letter · 2024-08-06 -
Our inspection documented approximately 84 open and past due deviation investigations existed as of June 21, 2024.
FDA · FDA Warning Letter · 2025-01-21 -
You failed to initiate or conduct adequate investigations into significant deviations in your aseptic processing manufacturing operations.
FDA · FDA Warning Letter · 2023-11-28
